Cleared Abbreviated

K991485 - SYNERGY POROUS SIZE 8 HIP STEM

K991485 is the FDA 510(k) clearance for SYNERGY POROUS SIZE 8 HIP STEM by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Abbreviated 510(k) pathway after a 75-day FDA review.

K991485 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
75d
Days
Class 2
Risk

K991485 is an FDA 510(k) clearance for the SYNERGY POROUS SIZE 8 HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on July 12, 1999 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K991485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1999
Decision Date July 12, 1999
Days to Decision 75 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 122d · This submission: 75d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 443
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K991485.
REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS
K991026 · Smith & Nephew, Inc. · Oct 1999
ENCORE FULLY COATED HIP
K992109 · Encore Orthopedics, Inc. · Aug 1999
TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE
K990135 · Zimmer, Inc. · Jul 1999
TITANIUM LOW PROFILE SCREWS
K991807 · Biomet, Inc. · Jul 1999
HEDROCEL ACETABULAR CAGE SYSTEM
K983837 · Implex Corp. · Jul 1999
MODIFICATION OF ENCORE LINEAR POROUS COATED HIP
K991325 · Encore Orthopedics, Inc. · Jun 1999